TABLE 4.

HCV genotype observed vs expected in the HCV TM-ASR assay^a

Sample	Genotypeb	Expected HCV RNA log IU/mlc	TM-ASR HCV RNA log IU/ml	Observed/ expected (%)
1	1a	5.78	6.18	107
2	1a	5.55	6.28	113
3	1a	5.75	6.68	116
4	1a	5.68	6.73	119
5	1a	5.43	5.65	104
6	1b	5.45	6.02	110
7	1b	4.97	5.25	106
8	1b	6.83	7.35	108
9	1b	4.59	4.11	89.4
10	1b	6.67	7.05	106
11	2b	5.64	5.73	102
12	2b	5.43	5.39	99.4
13	2b	5.74	6.06	105
14	2b	6.79	6.79	100
15	2b	6.54	6.99	107
16	3a	3.63	3.82	105
17	3a	3.29	3.06	92.9
18	3a	5.45	6.24	114
19	1a	5.57	6.63	119
20	4	5.80	6.92	119
21	4c/d	5.04	5.48	109
22	3a	5.80	6.66	115
23	4h	5.34	5.96	112
24	5a	6.66	6.92	104
25	5a	6.26	6.54	104

^aGenotype inclusively for the lot-specific HCV TM-ASR reagents using the Qiagen BioRobot 9604 was determined using clinical samples from eight different HCV genotypes purchased from Millennium Biotech (Ft. Lauderdale, FL). Genotype-specific samples were extracted using the QIAamp 96 virus/Qiagen BioRobot 9604 and amplified and detected using COBAS TaqMan ASR reagents on the COBAS TaqMan analyzer.

^bHCV genotypes were determined by Millennium Biotech.

^cExpected HCV RNA titers for each sample were obtained from Millennium Biotech.